CMS Issues National Coverage Decision Updating Policy for TAVR
June 21, 2019—The Centers for Medicare & Medicaid Services (CMS) announced it will continue to cover transcatheter aortic valve replacement (TAVR) under coverage with evidence development (CED) when furnished according to an FDA-approved indication. CMS stated that the decision to update the national coverage policy for TAVR comes in response to the continued development of this therapy and streamlines key elements of the original national coverage determination, which went into effect in 2012. CMS's full announcement is available online here.
The decision is consistent with recommendations from the meeting of the Medicare Evidence Development & Coverage Advisory Committee in July 2018 that provided CMS with an external review of medical literature, technology assessments, public testimony, and other data and information on the benefits, harms, and appropriateness of therapies under review.
CMS is also updating the coverage criteria for hospitals and physicians to begin or maintain a TAVR program, which provides greater flexibility for hospitals and providers to meet the requirements for performing TAVR.
CMS noted the decision includes updated volume requirements for hospitals and physicians to begin and maintain TAVR programs. Numerous stakeholders including medical professional societies recommended that these requirements for hospitals and physicians to perform a certain volume of heart procedures. Additionally, it aims to ensure that hospitals have the experience and capabilities to handle complex heart disease cases while limiting the burden and barriers that excessive requirements create for hospitals and patients.
CMS advised that it will continue to follow efforts by medical societies to develop TAVR-specific outcome measures, and the agency will encourage continued progress toward the establishment of such widely supported measures as potential replacements for procedural volume criteria.
Seema Verma, CMS Administrator, commented in the announcement, “Today’s decision to update and streamline the TAVR coverage parameters demonstrates CMS’s ongoing commitment to our beneficiaries. The modification to the TAVR hospital and physician requirements is generally consistent with the 2018 Consensus Statement from the American College of Cardiology, the American Association for Thoracic Surgery, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons. The decision ensures improved access to care for beneficiaries while supporting the continued evolution of this important technology in light of emerging evidence.”